dm+d

31144311000001107

Refrigerated Storage

BlincytoAmgen Ltd

Amgen Ltd
Blincyto
Powder for solution for infusion.

Contact Amgen Ltd in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

15 March 2021
London MI service

New Medicines

BlincytoPhiladelphia chromosome-positive, B-precursor, relapsed or refractory acute lymphoblastic leukaemia (ALL)

Information

Blincyto
Licence extension / variation
Amgen
Amgen

Development and Regulatory status

Launched
Launched
Launched
December 2020
Yes
Dec 20New indication approved in EU (and UK) [13].
Oct 20Recommended for EU approval by CHMP - the amended indication is "as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options" [12].
Nov 19Has been filed in the EU using the centralised procedure and the company expects a decision by the CHMP in May 20 [10].
Jul 17Approved in US for Philadelphia-positive ALL [9].
Feb 17Filed in US [7].
Dec 16Still listed as PII in Amgen pipeline [6].
Nov 15PII study is ongoing [4].

Category

CD19-specific, T cell-engaging BiTE antibody designed to direct a patients own T cells against cancer cells inducing a self-destruction process in cancer cells
ALL represents 12% of all leukaemia (but 80% in children). Peak age of incidence occurs between the ages of 2-4 years, decreasing to become a much rarer disease of adulthood. A smaller peak occurs in people aged over 50 years. [2]
Philadelphia chromosome-positive, B-precursor, relapsed or refractory acute lymphoblastic leukaemia (ALL)
Intravenous infusion

Further information

Yes

Trial or other data

Mar 17Journal of Clinical Oncology publishes results from the PII ALCANTARA study evaluating the efficacy and safety of blinatumomab in patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor ALL who had failed at least one second-generation or later tyrosine kinase inhibitor (TKI). The study (n=45) found that 16 patients (36%) achieved complete remission or complete remission with partial haematologic recovery within the first two cycles of treatment, with 14 of the 16 (31%) patients achieving complete remission with full haematologic recovery [11].
Jun 16PII Alcantara (NCT02000427) study is ongoing, but has completed recruitment and is expected to complete in Jan 17 [5].
Jul 15Topline results of PII single-arm multicentre clinical trial (NCT02000427) of Blincyto (blinatumomab) in adults with relapsed or refractory Philadelphia chromosome-positive (Ph+) B-cell precursor acute lymphoblastic leukemia (ALL) announced. Blinatumomab included complete remission or complete remission with partial hematological recovery within two treatment cycles in a clinically meaningful number of patients. Results were consistent with the drug’s safety profile. [1,3]

Evidence based evaluations

BlincytoPhiladelphia-negative high-risk B-precursor acute lymphoblastic leukaemia (ALL) in children - in first relapse

Information

Blincyto
Licence extension / variation
Amgen
Amgen

Development and Regulatory status

Launched
Launched
None
October 2021
Yes
Oct 21MHRA approves a licence extension for Blincyto. The new indication is use as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor ALL as part of the consolidation therapy [10].
Jun 21Licence extension approved in the EU [9].
May 21Recommended for EU approval by CHMP – the new indication is ‘Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor ALL as part of the consolidation therapy’ [8].
Nov 20Currently pre-registration in EU [4].
Jul 20Currently PIII. EU filing will be using the centralised procedure [2].
Jul 09Granted orphan drug status in EU (EU/3/09/650) [2].

Category

CD19-specific, T cell-engaging BiTE antibody designed to direct a patients own T cells against cancer cells inducing a self-destruction process in cancer cells
ALL is the most common cancer in children. Global incidence is about 3 per 100,000 population, with about 3 out of 4 cases occurring in children aged under 6 years. ALL represents 12% of all leukaemia (but 80% in children). Peak age of incidence occurs between the ages of 2-4 years, decreasing to become a much rarer disease of adulthood. A smaller peak occurs in people aged over 50 years [1].
Philadelphia-negative high-risk B-precursor acute lymphoblastic leukaemia (ALL) in children - in first relapse
Intravenous infusion

Trial or other data

Mar 21PIII NCT02393859 (n=108) is published; the study was terminated early as it found that blinatumomab was superior to chemotherapy for the third consolidation therapy prior to allogeneic hematopoietic stem cell transplant for event free survival (incidence of events in 31% vs. 57%, respectively, HR 0.33, 95%CI 0.18-0.61)[6].
Jul 20Results posted for PIII study (NCT02393859). Median EFS with blinatumomab was not estimable (12.0 to NA) vs. 7.4 months (4.5 to 12.7) in the chemotherapy group (p<0.001) [3].
Nov 15PIII study of blinatumomab vs standard chemotherapy in paediatric subjects With high-risk (HR) first relapse B-precursor ALL starts (NCT02393859). 108 children aged up to 17 years will be recruited in countries around the world including the EU & UK. Primary outcome is event-free survival; collection of these data is due to complete Jul 19 [3].